Vestibular Innovation in Pain: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Change in Pain numeric rating scale (NRS)
研究概览
简要总结
Fibromyalgia is the most common centralized pain disorder, affecting up to 3% of the population. Current treatments are incompletely effective, often poorly tolerated, and costly: there remains an urgent need for novel, effective, and well-tolerated therapy. Preliminary data suggests that vestibulocortical stimulation (VCS), or irrigating the external ear canal with temperate water, could rapidly improve pain and quality of life in this cohort. The VIPR trial will assess the efficacy of a single session of VCS - a safe & cost-effective bedside technique using a plastic syringe and temperate water - relative to sham in treating pain & improving quality of life using validated patient-reported outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
A blind-to-hypothesis approach will be used. Investigators and participants will not be blinded to temperature of water as the procedure itself does not lend to it.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Age equal to or >18 years old
- •Stated interest in and willingness to receive VCS and to complete the online patient reported outcomes before and after the procedure.
- •Owns or has access to a smart phone or computer to complete outcome measures
- •Fluency in English
- •Diagnosis of Fibromyalgia (FM)
- •Diagnosis by American College of Rheumatology 2016 questionnaire
- •Pain score 4/10 or more and less than 10/10 on the numeric rating scale at the time of inclusion.
排除标准
- •History of tympanic membrane injury, rupture, or surgery a. Including tympanostomy, or "ear tubes," and/or cochlear implant.
- •Right ear infection within the last 3 months, or current right ear pain.
- •Current pregnancy
- •Bipolar Disorder
- •History of seizures (including non-epileptiform seizures)
- •History of syncope within the last 3 months. a. Not including presyncope or in setting of known medical illness (i.e., heatstroke)
- •Inability to lay supine for 15 minutes
- •Receiving disability benefits for fibromyalgia or involved in litigation related to fibromyalgia.
- •Clinically significant medical, psychological, or behavioral conditions that, in the opinion of the investigator, would compromise participation in the study.
- •History of or current Meniere's Disease
- •History of myocardial infarction (MI), stroke or TIA, or coronary artery bypass graft (CABG) in the last 3 months
- •History of hospitalization for severe hypertension
- •History of vestibular schwannoma or meningioma resection.
- •Patients taking opioid therapy (not including tramadol).
研究组 & 干预措施
Vestibulocortical Stimulation
Participants will receive 50 cc of either warm or cold water irrigated into the right external ear canal at 1-2 cc/second.
干预措施: Vestibulocortical Stimulation (Procedure)
Sham Stimulation
Participants will receive 50 cc of either warm or cold water irrigated into the right external ear canal at 1-2 cc/second.
干预措施: Vestibulocortical Stimulation (Procedure)
结局指标
主要结局
Change in Pain numeric rating scale (NRS)
时间窗: Baseline and 1 week
Change in NRS as compared to baseline. Pain numeric rating scale (NRS), Full score on scale from 0-10 (0 = no pain; 10 = pain as bad as you can imagine). Higher scores indicate more pain.
次要结局
- Change in Pain numeric rating scale (NRS)(30 minutes, 24 hours, 2 weeks, 3 weeks, 4 weeks)
- Overall Well Being Scale(30 minutes)
- Patient Global Impression of Change (PGIC)(24 hr, 1 week, 2 weeks, 3 weeks, 4 weeks)
- Brief Pain Inventory (Short-Form; BPI-SF)(24 hrs, 1 week, 2 weeks, 3 weeks, 4 weeks)
- Patient Reported Outcomes Measurement Information System (PROMIS-29)(1 week, 2 weeks, 3 weeks, 4 weeks)
- Composite Autonomic Symptom Score-31 (COMPASS-31)(1 week, 2 weeks, 3 weeks, 4 weeks)
研究者
Michael H Kaplan
Assistant Professor of Medicine
Icahn School of Medicine at Mount Sinai